利拉利汀片说明书(英文)

1HIGHLIGHTSOFPRESCRIBINGINFORMATIONThesehighlightsdonotincludealltheinformationneededtouseTRADJENTAsafelyandeffectively.SeefullprescribinginformationforTRADJENTA.Tradjenta™(linagliptin)tabletsInitialU.S.Approval:2011----------------------------INDICATIONSANDUSAGE---------------------------TRADJENTAisadipeptidylpeptidase-4(DPP-4)inhibitorindicatedasanadjuncttodietandexercisetoimproveglycemiccontrolinadultswithtype2diabetesmellitus(1.1)Importantlimitationsofuse:•Shouldnotbeusedinpatientswithtype1diabetesorforthetreatmentofdiabeticketoacidosis(1.2)•Hasnotbeenstudiedincombinationwithinsulin(1.2)----------------------DOSAGEANDADMINISTRATION-----------------------•TherecommendeddoseofTRADJENTAis5mgoncedaily.TRADJENTAcanbetakenwithorwithoutfood.(2.1)---------------------DOSAGEFORMSANDSTRENGTHS----------------------Tablets:5mg(3)-------------------------------CONTRAINDICATIONS------------------------------Historyofhypersensitivityreactiontolinagliptin,suchasurticaria,angioedema,orbronchialhyperreactivity(4)-----------------------WARNINGSANDPRECAUTIONS------------------------•Whenusedwithaninsulinsecretagogue(e.g.,sulfonylurea),considerloweringthedoseoftheinsulinsecretagoguetoreducetheriskofhypoglycemia(5.1)•TherehavebeennoclinicalstudiesestablishingconclusiveevidenceofmacrovascularriskreductionwithTRADJENTAoranyotherantidiabeticdrug(5.2)------------------------------ADVERSEREACTIONS-------------------------------•Adversereactionsreportedin≥5%ofpatientstreatedwithTRADJENTAandmorecommonlythaninpatientstreatedwithplaceboincludednasopharyngitis(6.1)•HypoglycemiawasmorecommonlyreportedinpatientstreatedwiththecombinationofTRADJENTAandsulfonylureacomparedwiththosetreatedwiththecombinationofplaceboandsulfonylurea(6.1)•Pancreatitiswasreportedmoreofteninpatientsrandomizedtolinagliptin(1per538personyearsversuszeroin433personyearsforcomparator)(6.1)ToreportSUSPECTEDADVERSEREACTIONS,contactBoehringerIngelheimPharmaceuticals,Inc.at1-800-542-6257or1-800-459-9906TTY,orFDAat1-800-FDA-1088or:TheefficacyofTRADJENTAmaybereducedwhenadministeredincombination(e.g.,withrifampin).Useofalternativetreatmentsisstronglyrecommended.(7.1)-----------------------USEINSPECIFICPOPULATIONS------------------------•Pregnancy:Therearenoadequateandwell-controlledstudiesinpregnantwomen.TRADJENTAtabletsshouldbeusedduringpregnancyonlyifclearlyneeded.(8.1)•Nursingmothers:CautionshouldbeexercisedwhenTRADJENTAisadministeredtoanursingwoman(8.3)•Pediatricpatients:SafetyandeffectivenessofTRADJENTAinpatientsbelowtheageof18havenotbeenestablished(8.4)•Renalorhepaticimpairment:Nodoseadjustmentrecommended(8.6,8.7)See17forPATIENTCOUNSELINGINFORMATIONandFDA-approvedpatientlabeling.Revised:5/2011_______________________________________________________________________________________________________________________________________FULLPRESCRIBINGINFORMATION:CONTENTS*1INDICATIONSANDUSAGE1.1MonotherapyandCombinationTherapy1.2ImportantLimitationsofUse2DOSAGEANDADMINISTRATION2.1RecommendedDosing2.2ConcomitantUsewithaSulfonylurea3DOSAGEFORMSANDSTRENGTHS4CONTRAINDICATIONS5WARNINGSANDPRECAUTIONS5.1UsewithMedicationsKnowntoCauseHypoglycemia5.2MacrovascularOutcomes6ADVERSEREACTIONS6.1ClinicalTrialsExperience7DRUGINTERACTIONS7.1InducersofP-glycoproteinorCYP3A4Enzymes8USEINSPECIFICPOPULATIONS8.1Pregnancy8.3NursingMothers8.4PediatricUse8.5GeriatricUse8.6RenalImpairment8.7HepaticImpairment10OVERDOSAGE11DESCRIPTION12CLINICALPHARMACOLOGY12.1MechanismofAction12.2Pharmacodynamics12.3Pharmacokinetics13NONCLINICALTOXICOLOGY13.1Carcinogenesis,Mutagenesis,ImpairmentofFertility14CLINICALSTUDIES14.1Monotherapy14.2CombinationTherapy16HOWSUPPLIED/STORAGEANDHANDLING17PATIENTCOUNSELINGINFORMATION17.1Instructions17.2LaboratoryTests*Sectionsorsubsectionsomittedfromthefullprescribinginformationarenotlisted.ReferenceID:29407842FULLPRESCRIBINGINFORMATION1INDICATIONSANDUSAGE1.1MonotherapyandCombinationTherapyTRADJENTAtabletsareindicatedasanadjuncttodietandexercisetoimproveglycemiccontrolinadultswithtype2diabetesmellitus[seeClinicalStudies(14.1)].1.2ImportantLimitationsofUseTRADJENTAshouldnotbeusedinpatientswithtype1diabetesorforthetreatmentofdiabeticketoacidosis,asitwouldnotbeeffectiveinthesesettings.TRADJENTAhasnotbeenstudiedincombinationwithinsulin.2DOSAGEANDADMINISTRATION2.1RecommendedDosingTherecommendeddoseofTRADJENTAis5mgoncedaily.TRADJENTAtabletscanbetakenwithorwithoutfood.2.2ConcomitantUsewithaSulfonylureaWhenTRADJENTAisusedincombinationwithaninsulinsecretagogue(e.g.,sulfonylurea),alowerdoseoftheinsulinsecretagoguemayberequiredtoreducetheriskofhypoglycemia[seeWarningsandPrecautions(5.1)].3DOSAGEFORMSANDSTRENGTHSTRADJENTA(linagliptin)5mgtabletsarelightred,round,biconvex,bevel-edged,film-coatedtabletswith“D5”debossedononesideandtheBoehringerIngelheimlogodebossedontheotherside.4CONTRAINDICATIONSTRADJENTAiscontraindicatedinpatientswithahistoryofahypersensitivityreactiontolinagli